Remote medical examination

ABSTRACT

A platform, tips, and otoscope systems are described herein that can aid with evaluation of human ears (specifically children&#39;s ears), diagnose middle ear disease, and suggest appropriate treatments. The platform can serve as an end-to-end evaluation, treatment, and delivery of treatment to a user without requiring an office visit, and improves the accuracy of such systems and ease-of-use.

PRIORITY CLAIM

The present application claims priority from U.S. ProvisionalApplication No. 63/087,924, filed Oct. 6, 2020, which is hereby fullyincorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to medical diagnostic equipment for useat home. In particular, described herein are a system, device, andmethod that relate to detection and analysis of a tympanic membrane.

BACKGROUND

The subject matter of this patent document relates to a telemedicineplatform for evaluating ears, diagnosing lateral canal/tympanicmembrane/middle ear images (e.g., ear infection, ear fluid, or normal),prescribing treatment, counseling on supportive care measures, andfacilitating the delivery or delivering the treatment prescribed. Theplatform can provide a way for parents to care for their child's earpain with accurate diagnosis and timely treatment and minimize indirectcosts of care including missed work, transportation, and sunk childcarecosts. The minimum indirect costs of care for an ear infection areestimated to be $625. The additional physical and emotional toll ofcaring for a child who loses sleep and is in pain cannot be quantified.

It is more likely that mothers, rather than fathers, care for an illchild. These mothers need a solution that allows them to care for theirchild outside of normal working hours. In 2018, 65% of women withchildren under age 6 participated in the workforce, an increase from 39%in 1975. Working moms, in particular, can benefit from 24/7 access to animmediate assessment of their child's ears with treatment prescribed orguidance given for care. Women would otherwise need to take at least ahalf day off from work for an evaluation of their child's ears by ahealthcare provider. The alternative is a costly visit to the emergencyroom or urgent care during afterhours. On both a societal and individuallevel, the difficulties in balancing childcare with workresponsibilities contribute to stifling advancements in the workplace;this disproportionately affects women. A solution is needed thataddresses this imbalance that predominantly affects mothers.

A typical child's ear canal is tortuous. It is a hallway that ends atthe tympanic membrane but has twists and turns that have been studied.Mean anterior canal angle is 148 degrees and the mean inferior canalangle is 146 degrees. Because of this, the user of an otoscope has toidentify an optimal view of the TM by angling and moving the otoscopetip. It can be difficult for home healthcare providers (e.g., parents)to navigate this using a conventional straight otoscope tip andrecognize the anatomical structures within view.

Children benefit from care that is not delayed and from which theyreceive a reliably accurate diagnosis. In contrast, the mean diagnosticaccuracy for ear infections and middle ear fluid by pediatricians isabout 50%. This results in an abundance of over diagnosis of earinfections and over prescribing antibiotics. Ear infections play a largepart in the care required for young children; they are one of the mostcommon reasons for children to seek care in the US.

Not only can children have reactions to medications that might not bewarranted, but inappropriate use of antibiotics drives antibioticresistance within society. Society can benefit from appropriateantibiotic use when the diagnosis is more accurate.

SUMMARY

In embodiments disclosed herein, a platform for ear infection detectionin children that addresses the above-identified problems is discussed.The platform disclosed serves to evaluate children's ears at any time ofthe day to provide the parent with an accurate diagnosis and appropriatetreatment, including prescription antibiotics or supportive caremeasures. Parents are prompted to photograph their child's ear drumswith a smartphone otoscope attachment. An algorithm analyzes the imagesand potentially yields a diagnosis with accuracy superior to the meanaccuracy for pediatricians and ENT surgeons, 50% and 73%, respectively.The algorithm provides artificial intelligence, and can be based onmachine learning, deep learning, or a convolutional neural network, forexample. The success of the platform hinges on its diagnostic accuracy,which necessitates that the inputs to the algorithm are labeledaccurately. Since physicians cannot achieve 100% accuracy, simplylabeling images by a physician will not achieve this. Instead, bylinking an image to the surgical findings of what is directly visualizedin the middle ear space at the time of myringotomy (hole in the ear drummade for ear tube placement), up to 100% accuracy of the inputs to trainand test the algorithm can be achieved. Machine learning-enabled, homediagnostics for middle ear disease is novel, transformative, anddisruptive. Current state of the art for at home diagnostics consists ofhealthcare providers struggling to see the ear drum through telemedicineor on-call providers prescribing antibiotics for a presumed infectionwithout having examined the ear drum.

Success of a platform such as is disclosed herein hinges on its accuracyand its usability. Accurate outputs depend on accurate inputs. Accuratelabeling of training images only occurs when the middle ear status isdefined by findings when a myringotomy is made (incision in the eardrum) or when the middle ear space is aspirated with a needle throughthe ear drum. For example, this can be achieved by photographing the eardrum directly before an incision is made in it for placing ear tubes.Once the incision is made, the contents of the middle ear space willcome through and are visible to the ENT surgeon. This allows for 100%accurate labeling of the image as being normal, having fluid, or havinginfection in the middle ear space. The presence of fluid is thedefinition of “otitis media with effusion” and the presence of infectedfluid is the definition of “acute otitis media.” The latter is treatedwith antibiotics while the former is not. It is believed thatmisdiagnosis of infection and over prescription of antibiotics is asignificant contributor to antibiotic resistance within society.

According to an embodiment, a system is described that includes aweb-based application consisting of software that, used in conjunctionwith angled otoscope tips, can evaluate human ears, diagnose middle eardisease, suggest appropriate treatment for the diagnosis, offerrecommendations for supportive care, send in prescription to a pharmacy,and deliver the medication to the user's home, wherein the platform canserve as an end-to-end evaluation, treatment, and delivery of treatmentto a user without leaving the locale that they interact with theplatform.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an otoscope tip, according to anembodiment.

FIG. 2 is a perspective view of the otoscope tip, according to theembodiment depicted in FIG. 1.

FIG. 3 is a cross-sectional side view of the otoscope tip, according toan embodiment.

FIG. 4 is a cross-sectional side view of the otoscope tip, according toan embodiment.

FIG. 5 is a perspective view of the otoscope tip, according to anembodiment.

FIG. 6 is a perspective view of the otoscope tip, according to theembodiment depicted in FIG. 5.

FIG. 7 is a perspective view of the otoscope tip, according to anembodiment.

FIG. 8 is a flow diagram illustrating the user interaction with theplatform.

DETAILED DESCRIPTION OF THE DRAWINGS

In general, described herein are apparatuses and methods for the visualdetection of the tympanic membrane (TM) and diagnosis of the middle ear,specifically that of a child. These apparatuses and methods areconfigured for use by a non-healthcare professional, such as a parent orcaregiver. One such system described herein comprises a camera, light,otoscope, otoscope tip, and web-based application. The otoscope may bean otoscope typically used in a clinical setting or a smartphoneotoscope attachment. The camera and/or light may be part of thetraditional otoscope or may be the smartphone camera and light. Variousembodiments of the otoscope tip exist, including (but not limited to)those illustrated in FIGS. 1-6.

One embodiment of otoscope tip 100 is shown in FIGS. 1 and 2. Otoscopetip 100 comprises a distal end 120, a substantially conical portion 140,a substantially cylindrical portion 160, and a proximal end 180.Throughout this application, “distal” and “proximal” are used to referto the direction and distance relative to the patient. In use, thedistal end 120 mounted onto the speculum of an otoscope. The user caninsert the proximal end 180 into the ear and guides the cylindricalportion 160 along the ear canal.

In general, the most useful information for identifying an ear infectionis “downward-and-forward facing” image capture. By “forward,” thisdisclosure refers to photographs facing toward the face from the insideof the ear canal. By “downward,” this disclosure refers to photographsfacing towards the bottom of the patient's ear when the patient isupright/standing. Some specific examples of sizes and angles that can beused to obtain such images are described with respect to FIGS. 3-6. Ingeneral, though, the tips described herein remove the reliance on theuser to obtain the view but rather allow the tip to guide and obtain theview in a fail-safe way. It should be understood that the features shownin FIGS. 1 and 2 could be sized and shaped to accomplish this result.Obtaining a forward and downward facing image of the medial ear canalmaximizes the likelihood of capturing and image that contains themajority of the tympanic membrane. This is due to the anatomy of earcanals in children typically coursing forward and slightly down from theopening that is seen in the outer ear. In adolescents and adults, theforward facing is similar but the downward facing gaze into the earcanal is much less necessary. Young children have the highest rates ofear infections in the population. This tip can theoretically be used forboth ears, just simply rotated 180 degrees. In that case, there would bemarkings on the base to instruct on use for each side. Having clearinstructions on the tip improves usability and safety.

Additionally, the tips described herein at FIGS. 1-6 could have coatingsor other features that help to eliminate or clear wax. Ear wax canobstruct views of the relevant portions of the ear that are indicativeof infections or other conditions. A coating applied to the tips canimprove the images obtained.

In alternative embodiments illustrated in FIGS. 3 and 4, otoscope tip200 is configured to solely accommodate the anterior angle of a child'sear canal. Throughout this application, like parts within differentembodiments are described using like reference numbers, iterated by amultiple of 100. That is, similarly to the embodiments shown in FIGS. 1and 2, otoscope tips 200 and 200′ shown in FIGS. 3 and 4, respectively,each comprise a distal end 220, a substantially conical portion 240, asubstantially cylindrical portion 260, and a proximal end 280. Otoscopetips 200 and 200′ may have the same overall length L, distal enddiameter X, and proximal end diameter Y. Otoscope tip 200′, however, isconfigured for the ear canal of an older child. As a child grows, his orher ear canal lengthens. To reflect this lengthening, the location ofthe angle, between the conical portion 240 and the cylindrical portion260, is farther from the distal end 220 in otoscope tip 200′ than inotoscope tip 200. Therefore, the interior angles φ and φ′ of otoscopes200 and 200′, respectively, are such that φ>φ′. In a particularembodiment, otoscope tips 200 and 200′ may have overall length L=1.59mm, distal end diameter X=0.956 mm, proximal end diameter Y=0.165 mm,anterior angles θ=θ′=148°, interior angle φ=170°, and interior angleφ′=165°. It should be understood that these values are approximate andcan vary over the age of the child, such that the anterior and inferiorangles can become more shallow or less pronounced and the diameter ofthe canal increases.

Rather than bend around the anterior and inferior angles of the earcanal, alternative embodiments of the otoscope tip position the otoscopein optimal position, as shown in FIGS. 5-7. Similar to otherembodiments, otoscope tip 300 comprises a distal end 320, asubstantially conical portion 340, a substantially cylindrical portion360, and a proximal end 380. In this embodiment, conical portion 340further comprises an asymmetrically projecting extension 330. Theextension 330 supports and suspends the otoscope in the ear,accommodating the angles of the ear canal without bending the trajectoryof the light.

As shown in FIGS. 5 and 6, an embodiment is made to accommodate theanterior and inferior angles of a child's ear without necessarilybending around them but rather positioning the rigid otoscope in optimalposition. When the otoscope is connected to the tip, its position startsposterior and superior at the base of the tip (end closer to the outsideworld) and ends anterior and inferior at the distal end of the tip (inthe ear canal, end closer to the TM). In doing this, the otoscope issupported but suspended in the ear canal in a way that accommodates theangles of the child's ear canal. The length of the tip is meant toaccommodate the length of the canal where the natural angles occur, andcan be sized as described above with respect to FIGS. 1-4. In a kitembodiment, because the child's ears will spiral in the opposite wayfrom one another, two separate tips (one for right ear and one for leftear) would be provided for use with an otoscope or camera.

An embodiment like that illustrated in FIGS. 5 and 6 is shown in FIG. 7.Otoscope tip 400 of FIG. 7 comprises a distal end 420, a substantiallyconical portion 440, a substantially cylindrical portion 460, and aproximal end 480. In this embodiment, the substantially conical portion440 further comprises a flange 410 as well as an asymmetricallyprojecting extension 430. The flange 410 provides further support to theposition of the otoscope within the ear and prevents it from falling ortraveling too far into the ear canal. By controlling the depth of theotoscope tip 400, flange 410 improves alignment of the otoscope tip 400with the ear canal and maintains focal distance for the camera, therebyincreasing the success of image capture.

Otoscope tip 100 in FIGS. 1 and 2 is configured to accommodate a child'sear canal with respect to both the anterior angle, which as a mean angleof 148 degrees, and the inferior angle, which has a mean angle of 146degrees. This geometric accommodation produces handedness and requiresthat two distinct tips be used, one for the left ear and one for theright ear. Two counterpart versions of otoscope tip 300 can be used forapplication to both ears. Unlike these embodiments, otoscope tip 200 andotoscope tip 200′ may each be used for both ears if rotated 180 degrees.

Instructions referring to the body's anatomy or general spatialdirections may be provided on the surface of the device to orient theappropriate position in the ear. Instructions may be written and/orpictorial. General spatial directions can include written words orsymbols. There can be one or more sets of orienting images, symbols, ordirections. Each set of orienting images, symbols, or directions can becolor coded such that the color corresponds to instructions for one ear,and a separate color for the opposite ear. Providing instructionsincreases user ease and comfort as well as aids the success ofauto-capture and visual classification.

Prior to using the otoscope, the parent (or other user) completes amedical history questionnaire, as indicated by the flow diagram in FIG.8. The parent is then prompted to use the otoscope and otoscope tipsystem to take photos, which are then submitted to the web-basedapplication. The application's software employs a machine learningalgorithm to evaluate the photos. The platform disclosed serves toevaluate children's ears at any time of the day to provide the parentwith an accurate diagnosis and appropriate treatment, includingprescription antibiotics or supportive care measures. The platformdisclosed can provide the parent with recommendations which include theneed to seek care in person or via telemedicine or to continuesupportive treatment at home. Parents are prompted to photograph theirchild's ear drums with a smartphone otoscope attachment. An algorithmanalyzes the images and potentially yields a diagnosis with accuracysuperior to the mean accuracy for pediatricians and ENT surgeons, 50%and 73%, respectively. The algorithm provides artificial intelligence,and can be based on machine learning, deep learning, or a convolutionalneural network, for example. The success of the platform hinges on itsdiagnostic accuracy, which necessitates that the inputs to the algorithmare labeled accurately. Since physicians cannot achieve 100% accuracy,simply labeling images by a physician will not achieve this. Instead, bylinking an image to the surgical findings of what is directly visualizedin the middle ear space at the time of myringotomy (hole in the ear drummade for ear tube placement), up to 100% accuracy of the inputs to trainand test the algorithm can be achieved.

Machine learning-enabled, home diagnostics for middle ear disease isnovel, transformative, and disruptive. Current state of the art for athome diagnostics consists of healthcare providers struggling to see theear drum through telemedicine or on-call providers prescribingantibiotics for a presumed infection without having examined the eardrum.

Success of a platform such as is disclosed herein hinges on its accuracyand its usability. Accurate outputs depend on accurate inputs. Accuratelabeling of training images only occurs when the middle ear status isdefined by findings when a myringotomy is made (incision in the eardrum) or when the middle ear space is aspirated with a needle throughthe ear drum. For example, this can be achieved by photographing the eardrum directly before an incision is made in it for placing ear tubes.Once the incision is made, the contents of the middle ear space willcome through and are visible to the ENT surgeon. This allows for 100%accurate labeling of the image as being normal, having fluid, or havinginfection in the middle ear space. The presence of fluid is thedefinition of “otitis media with effusion” and the presence of infectedfluid is the definition of “acute otitis media.” The latter is treatedwith antibiotics while the former is not. It is believed thatmisdiagnosis of infection and over prescription of antibiotics is asignificant contributor to antibiotic resistance within society.

The training images should include “real world” or high fidelitycompared to what a parent can achieve at home in addition to images thatphysicians can achieve in the operating room or in the office.Manipulation of images to replicate various angles, out of focus,portions of ear drums (rather than entire ear drum), and images with waxpartially obstructing the view of the ear drum are all ways that thetraining images can be used to help replicate real world images thatparents can achieve at home. Multiple photographs can be taken of eachear drum to build the training image set. They can be taken before anyear wax is removed so that the native state of the ear canal can becaptured. If no portion of the ear drum can be seen, then these imagescan be labeled as “cannot assess” so that when interacting with theplatform, a child will be referred appropriately to their healthcareprovider for an assessment rather than the algorithm attempting to labelwith a diagnosis. An image can be taken after the ear is cleaned toreveal the entire ear canal and ear drum. The images can also be takenwith high definition surgical instruments such as endoscopic cameras orthey can be taken with a commercially available smart phone otoscopeattachment. The latter can provide an image quality similar to whatparents could achieve in the home setting. If there is reasonablefidelity between future home images and the images that the algorithm istrained and tested with, the accuracy of the algorithm found in testingshould translate to home use.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPGAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor” as used herein may refer toany of the foregoing structure or any other physical structure suitablefor implementation of the described techniques. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

1. A system for at-home imaging of a child's ear canal and diagnosis ofmiddle ear disease, the system comprising: a light source configured toilluminate the ear canal; a camera configured to providedownward-and-forward facing images of the ear canal; an otoscope; and aweb-based application configured to: receive the downward-and-forwardfacing images from the camera; autonomously capture thedownward-and-forward facing images depicting at least a portion of atympanic membrane; and autonomously classify the at least portion of thetympanic membrane from the captured downward-and-forward facing imagesto indicate the status of the middle ear.
 2. The system of claim 1,wherein the camera is located within a smartphone otoscope attachment.3. The system of claim 1, wherein the web-based application isconfigured to provide an output indicative of a normal ear, middle earfluid (“otitis media with effusion”), middle ear infection (“acuteotitis media”), or insufficient image capture.
 4. The system of claim 1,wherein the web-based application comprises a machine learning softwarecomponent that has been trained with images of the same resolution asthe camera.
 5. The system of claim 4, wherein the software has beentrained with images that include a rim of an at-home otoscope tip. 6.The system of claim 4, wherein the software has been trained with imagestaken at a variety of angles and orientations.
 7. The system of claim 4,wherein the software has been trained with images that include cerumenat least partially blocking the view of the tympanic membrane.
 8. Thesystem of claim 1, further comprising a coating applied to the at leastone otoscope tip, the coating configured to dissolve, displace, andrepel obstructing cerumen.
 9. The system of claim 1, wherein the atleast one otoscope tip can be used for both ears.
 10. The system ofclaim 1, wherein the at least one otoscope tip includes an otoscope tipconfigured for use with a left ear and an otoscope tip configured foruse with a right ear.
 11. The system of claim 1, wherein the at leastotoscope tip includes a plurality of otoscope tips.
 12. The system ofclaim 1, wherein the otoscope tip accommodates the mean angle of theanterior ear canal (148 degrees) and the mean angle of the inferior earcanal (146 degrees).
 13. The system of claim 1, wherein the otoscope tipis configured to suspend the otoscope in the ear canal.
 14. An otoscopetip that is mountable onto an otoscope, the tip comprising: a distal endconfigured to receive an otoscope; a substantially conical portion thatnarrows as it extends from the distal end; and a substantiallycylindrical portion coupled to the substantially cylindrical portion toa proximal end, wherein the otoscope tip comprises an optical pathwayextending through the substantially conical portion and thesubstantially cylindrical portion, wherein an anterior angle formedbetween the substantially conical portion and the substantiallycylindrical portion is between about 146 and about 148 degrees, andwherein an interior angle of the optical pathway between thesubstantially conical portion and the substantially cylindrical portionis between about 165 and about 170 degrees.
 15. The otoscope tip ofclaim 14, further comprising a coating configured to dissolve cerumen.16. An automated method for at-home imaging of the ear canal anddiagnosis of middle ear, the method comprising: attaching an otoscopetip to an otoscope, the otoscope tip comprising: a distal end configuredto receive an otoscope; a substantially conical portion that narrows asit extends from the distal end; and a substantially cylindrical portioncoupled to the substantially cylindrical portion to a proximal end,wherein the otoscope tip comprises an optical pathway extending throughthe substantially conical portion and the substantially cylindricalportion, wherein an anterior angle formed between the substantiallyconical portion and the substantially cylindrical portion is betweenabout 146 and about 148 degrees, and wherein an interior angle of theoptical pathway between the substantially conical portion and thesubstantially cylindrical portion is between about 165 and about 170degrees; guiding the otoscope into the ear canal; illuminating the earcanal with a light source; obtaining images of the ear canal via theotoscope; providing a web-based application configured to: receive thedownward-and-forward facing images from the camera; autonomously capturethe downward-and-forward facing images depicting at least a portion of atympanic membrane; and autonomously classify the at least portion of thetympanic membrane from the captured downward-and-forward facing imagesto indicate the status of the middle ear.
 17. The automated method ofclaim 16, wherein the web-based application is configured to provide anoutput indicative of a normal ear, middle ear fluid (“otitis media witheffusion”), or middle ear infection (“acute otitis media”), orinsufficient image capture.
 18. The automated method of claim 16,wherein the web-based application comprises a machine learning softwarecomponent that has been trained with images of the same resolution asthe camera.
 19. The automated method of claim 18, wherein the softwarehas been trained with images that include a rim of an at-home otoscopetip.
 20. The automated method of claim 18, wherein the software has beentrained with images taken at a variety of angles and orientations.